Blood extracellular vesicles as markers of lung involvement in LAM and TSC.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will collect clinical and functional data plus blood samples from adult women with definite sporadic LAM or TSC-associated LAM during routine outpatient visits at the Pulmonology Unit of ASST Santi Paolo e Carlo in Milan. Plasma will be separated and extracellular vesicles (EVs) will be isolated by centrifugation and characterized for size, concentration, and molecular cargo including proteins, lipids, and nucleic acids. EV results will be correlated with pulmonary function tests and other clinical measures to look for patterns linked to lung involvement. The protocol uses non-invasive blood sampling and standard laboratory EV analysis methods to identify candidate biomarkers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Female participants aged ≥18 years Confirmed diagnosis of tuberous sclerosis complex (TSC) and/or lymphangioleiomyomatosis (definite diagnosis of TSC-LAM or S-LAM) Follow-up at the Pulmonology Unit of ASST Santi Paolo e Carlo, Milan Ability to provide written informed consent

Exclusion Criteria:

Diagnosis of "probable" or "possible" LAM Refusal to provide written informed consent

Where it's running

• Pulmonology Unit ASST Santi Paolo e Carlo, Ospedale San Paolo
  Milan, Milano, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.